FDA approved Darzalex (daratumumab) Sept. 26 in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed adult patients with multiple myeloma who are eligible for autologous stem cell transplant.
The Janssen Pharmaceutical Companies of Johnson & Johnson sponsors Darzalex.
The approval is based on results from the phase III CASSIOPEIA (MMY3006) study that showed the addition of Darzalex to VTd before and after ASCT resulted in deeper responses, as indicated by the higher stringent complete response rate, and improved progression-free survival compared to VTd alone. The approval comes after FDA granted Priority Review for the supplemental Biologics License Application.
“The pivotal phase III CASSIOPEIA study is one of the largest transplant studies ever conducted in multiple myeloma, and the largest study conducted with daratumumab,” said Philippe Moreau, principal investigator and head of the hematology department at the University Hospital of Nantes, France. “It’s important that patients get a deep response from their frontline therapy, and CASSIOPEIA demonstrates that the addition of daratumumab to VTd before and after transplant markedly increased depth of response compared to VTd alone for patients with newly diagnosed multiple myeloma.”
Data from the phase III CASSIOPEIA study were first presented at the 2019 American Society of Clinical Oncology Annual Meeting and simultaneously published in The Lancet. Additionally, updates from the study were recently presented at the 17th International Myeloma Workshop Meeting.
CASSIOPEIA is a two-part, Intergroupe Francophone du Myelome study in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology and Janssen Research & Development, LLC. Results from this first part of the trial showed that the primary endpoint of sCR rate post consolidation was significantly higher in the Darzalex-VTd arm compared to VTd alone (29% vs. 20%) (Odds Ratio = 1.60; 95% confidence interval, 1.21–2.12; P=0.0010). The addition of Darzalex to VTd at a median follow-up of 18.8 months resulted in a 53% reduction in the risk of disease progression or death compared to VTd alone (Hazard Ratio [HR] = 0.47; 95% CI, 0.33–0.67; P<0.0001).1
After consolidation, Darzalex-VTd also increased the rate of complete response or better (39% vs. 26%) (OR = 1.82; 95% CI, 1.40-2.36) and very good partial response or better (83% vs. 78%) (OR = 1.41; 95% CI, 1.04-1.92) compared to VTd alone, respectively.
“The Darzalex clinical development program has led to many important firsts, but more importantly, it has generated key insights and understanding into the biology and treatment of multiple myeloma,” said Craig Tendler, vice president of clinical development and global medical affairs in oncology at Janssen Research & Development, LLC.
This news comes on the heels of the second approval of Darzalex for treatment of newly diagnosed patients with multiple myeloma who are transplant-ineligible, based on the phase III MAIA study.
